FDA Demands Man Stop Giving Away Sperm

HUFFINGTONPOST.COM - Last fall, the Food and Drug Administration hand-delivered an order
to cease manufacturing to a seemingly unremarkable recipient, a
soft-spoken, 36-year-old man from Fremont, Calif., who works in computer
security. The contents of that letter, however, were anything but
ordinary. The agency was demanding that Trent Arsenault comply with
federal regulations or stop giving away his fresh semen to women hoping
to have a baby.

Since Arsenault made his first free sperm donation in 2006, answering
a Listserv request from a Bay Area teacher who is now mother to a
4-year-old boy, he claims to have fathered 13 children, with four more
on the way. Arsenault posts this information, as well as details about
his appearance (blonde hair, brown eyes), hobbies (bird watching, Native
American history) and what he calls his "sperm donor friendly diet"
(twice daily fruit-and-raw-milk smoothies) on his website, Trentdonor.org.
The site provides his latest physicals and tests for sexually
transmitted diseases, and explains how women wanting to use his sperm
can contact him.

The real trouble for Arsenault began in 2010, when the FDA's Center
for Biologics Evaluation and Research inspected his home and found him
in violation of numerous regulations, including failing to properly
protect himself against communicable diseases. A year earlier, an FDA
investigator had emailed Arsenault, requesting an opportunity to discuss
the activities advertised on his website. During the meeting, Arsenault
completed what is known as a human cells and tissues establishment
registration form, indicating he was a "directed" or known donor and, as
such, subject to federal regulation. Arsenault admits he filled out the
form not because he fully understood its meaning and implications, but
because he was eager to comply with the FDA's wishes.

Since that time, Arsenault has been fighting the agency's efforts to
shut him down -- in particular, disputing the notion that he is a
"manufacturer" of sperm, given that he packages his semen and
distributes it in a cup. He has petitioned for a hearing to prove that
even though he does not have sex with his recipients, he is a sexually
intimate partner to them (a term the FDA currently does not define) and
therefore is exempt from regulatory requirements that apply to
manufacturers.

So far, Arsenault's requests have been denied, and he now faces
potential financial penalties and jail time. What the FDA decides to do
with the case, however, has consequences beyond Arsenault's fate, for it
has stirred debate within a small pocket of the world of assisted
reproduction about what sexual intimacy is and whether the government
really wants any part of that discussion.

"Trent believes he is a sexually intimate partner with these women,"
said Daniel Epstein, executive director of Cause of Action, the
Washington, D.C.-based public interest nonprofit representing him. "And
it shouldn't be up to the FDA to define how private individuals define
intimacy." click here to read more

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